Kornimate/medical-research-clean huggingface dataset:
breast cancer genes(brca) expressions in metastatic gastric cancer

Conditions: BRCA Gene Rearrangement

Summary: the investigators evaluated the incidence of brca loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to brca loss. and the investigators evaluated the possibility of brca loss as a predictive and prognostic factor.

stomach cancer is still the leading cause of cancer deaths globally and is reported to be the second leading cause of cancer deaths in korea (18.7%). although the number of radical resection has increased due to the development of early diagnosis, many patients experience recurrence after radical resection. it is also diagnosed as a non - resectable disease locally advanced at the time of initial diagnosis, or with a metastasis. in patients with recurrent / metastatic gastric cancer, conventional palliative chemotherapy is the best treatment, and in advanced gastric cancer, combination therapy with fluoropyrimidine (fluorouracil, capecitabine, s1) and platinum (oxaliplatin, cisplatin). the progression-free survival was 3-5 months, and overall survival of 6-10 months in metastatic gastric cancer patients. the investigators evaluated the incidence of brca loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to brca loss. and the investigators evaluated the possibility of brca loss as a predictive and prognostic factor.

Eligibility criteria:
inclusion criteria: * metastatic gastric cancer( adenocarcinoma) * eastern cooperative oncology group (ecog) performance 0-2 * one more measure lesion * white blood cell count (wbc) \> 3000/ul , platelet \> 75,000/ul * normal kidney function (serum creatinine \< 1.5 uln) * normal liver function (aspartate aminotransferase (ast)/ alanine aminotransferase (alt) \< 3 times of upper normal limit, if liver metastasis, ast/alt \< 5 times of upper normal limit) * life expectancy is more than 3 months * conventional surgery that does not cause the transformation of the target lesion is allowed * the patient who voluntarily decided to participate in this study and agreed in writing exclusion criteria: * her-2 positive advanced gastric cancer * central nervous system metastases requiring treatment with symptoms * major uncontrolled cardiovascular disease (including myocardial infarction and congestive heart failure within 6 months) * uncontrolled infection or other serious diseases * patients with serious medical conditions or serious illnesses * patient who is pregnant or lactating * adjuvant chemotherapy before 6 months (patients who have not received platinum-based chemotherapy even if they are 6 months old can register) * in the past, if the primary lesion or target lesion was treated with radiation (if the recurred lesion is outside the range of radiation therapy)

Keywords: stomach cancer chemotherapy folfox capecitabine plus oxalipatin (capox)
aviptidil for severely ill inpatients with covid-19 (an activ-3b/tesico treatment trial)

Conditions: Covid19

Summary: this study looks at the safety and effectiveness of aviptidil in treating covid-19 in people who have been hospitalized with the infection and who have acute respiratory failure. participants in the study will be treated with aviptidil plus current standard of care (soc), or with placebo plus current soc.

this is a treatment trial of the activ-3b/tesico master protocol (nct04843761) to evaluate the safety and efficacy of aviptidil at improving outcomes for patients with acute respiratory failure related to covid-19. this protocol will be adaptive, randomized, blinded and initially placebo-controlled. participants will receive standard of care (soc) treatment as part of the protocol. this protocol will be conducted in up to several hundred clinical sites. participating sites are affiliated with networks funded by the united states national institutes of health (nih) and the us department of veterans affairs. the protocol is for a phase 3 study. participants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints. selected secondary endpoints will be measured at 180 days. this study is planned to provide 80% power to detect an odds ratio of 1.5 for improvement in recovery status at day 90 for aviptidil versus placebo with use of the ordinal outcome. the planned sample size is 320 participants. sample size may be re-estimated before enrollment is complete based on an assessment of whether the pooled proportions of the outcome are still consistent with adequate power for the hypothesized difference measured by the odds ratio. randomization will be stratified by study site pharmacy and by receipt of invasive mechanical ventilation, or ecmo (extracorporeal membrane oxygenation) at enrollment. other agent-specific stratification factors may be considered. an independent data and safety monitoring board (dsmb) will review interim safety and efficacy data at least monthly. pre-specified guidelines will be established to recommend early stopping of the trial for evidence of harm or substantial efficacy. the dsmb may recommend discontinuation of an investigational agent if the risks are judged to outweigh the benefits.

Eligibility criteria:
inclusion criteria: refer to the master protocol (nct04843761) exclusion criteria: refer to the master protocol (nct04843761) additional exclusion criteria: * refractory hypotension * severe diarrhea * current c. difficile infection * pregnancy or current breast-feeding * end-stage liver disease

Keywords: covid-19 covid 19 coronaviridae infections coronavirus infections rna virus infections virus diseases nidovirales infections sars-cov-2 sars coronavirus activ-3 activ3
wise interventions in the digital society

Conditions: Cyberbullying; Grooming; Risk Behavior

Summary: this study evaluates the effectiveness of a wise intervention based on self-affirmation (sa) and implicit theories of personality (itp) in spanish adolescents and young people. half of participants will receive the itp and self-affirmation intervention, while the other half will receive a control intervention.

adolescence is a period that involves important transitions and learning opportunities. adolescents and young people learn and develop new competencies and facets in the digital society. hence, a large part of their social relationships takes place through social media.this offers them numerous positive opportunities for the emotional and social development of adolescents and young people. they can develop positive interactions through prosocial behaviors, empathy, and social support towards others. at the same time it is not without potential risks, especially in adolescence, a stage of psychological vulnerability for risky behaviors. very recently, interest in scientific social psychology has grown due to a new approach to interventions, which have been called "wise interventions." this approach involves a set of rigorous techniques, based on theory and research, that address specific psychological processes to help people thrive in various life environments. the main objective of this project is to design and evaluate the effectiveness of a wise intervention based on self-affirmation (sa) and implicit theories of personality (itp) to promote various online prosocial behaviors (help, empathy, collaboration) and prevent online risk and harassment behaviors (online bullying, sexting, grooming). secondary objectives are (1) to assess the moderating role of gender and the degree of evolutionary development of adolescents and young people, and (2) to evaluate potential mediating mechanisms for the effectiveness of the interventions. the study will involve the evaluation of the intervention in a sample of around 1000 young and adolescents randomly allocated to experimental and control condition.

Eligibility criteria:
inclusion criteria: * informed consent by the adolescents and their parents. * to be fluent in spanish and/or euskera. exclusion criteria: * lack of permission by parents and the adolescent. * lack of understanding of the instructions.

Keywords: adolescence youth cyberbullying grooming sexting prevention
atorvastatin three year pediatric study

Conditions: Familial Hypercholesterolemia

Summary: the purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, tanner stage) and efficacy of cholesterol reduction in pediatric subjects with heterozygous familial hypercholesterolemia receiving atorvastatin treatment.


Eligibility criteria:
inclusion criteria: * heterozygous familial hypercholesterolemia, ages 6-15, ldl greater than 4 mmol/l exclusion criteria: * active liver disease or hepatic dysfunction, or persistent elevations of serum transaminases exceeding three times the upper limit of normal (uln). female of childbearing potential who is not using adequate contraceptive measures or any female who is pregnant or breastfeeding. any female who becomes pregnant during study participation will be immediately discontinued from treatment and counseled appropriately about the in utero exposure. known hypersensitivities to hmg-coa reductase inhibitors

Keywords: pediatric heterozygous familial hypercholesterolemia
establishment of radiomics database by clinical application of multiparametric mri based on incoherent undersampling

Conditions: Pancreas Cancer

Summary: this study aims to establish radiomics database for pancreas cancer from multiparametric mri including dce-mri obtained by using incoherent undersampling and radial acquisition for clinical staging as well as quantitative analysis.


Eligibility criteria:
inclusion criteria: * surgical candidate for pancreatico-duodenectomy * characteristic finding of pancreatic adenocarcinoma on prior ct or mri * or histologically diagnosed with pancreatic adenocarcinoma * signed for informed consent exclusion criteria: * under 18 years * not eligible for pancreatico-duodenectomy * unresectable patients (locally advanced on prior ct/mri or metastatic disease) * tumors with suspicion of other histologic types (neuroendocrine, ipmn, etc) * any contra-indication of contrast-enhanced mri * recurred pancreatic cancer

Keywords: mri
efficacy and immunogenicity study of recombinant human papillomavirus bivalent（type 16/18 ）vaccine

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection

Summary: this is a phase iii clinical trial of the novel recombinant hpv 16/18 bivalent vaccine manufactured by xiamen innovax biotech co., ltd. the primary objective of this study is to demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18 years old at enrolment. the secondary objectives are to evaluate the safety, immunogenicity and immuno-persistence of the vaccine. meanwhile, this study tries to compare the difference of safety and immunogenicity among different lots. approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive human papillomavirus (hpv) vaccine(three different lots) or commercialized hepatitis e vaccine(hecolin) according to a 0-1-6 month schedule.


Eligibility criteria:
inclusion criteria: 1. female subjects between, and including, 18 and 45 years of age at the first vaccination; 2. healthy subjects as established by medical history and history-oriented clinical examination; 3. be able to understand and comply with the request of the protocol; 4. without acute cervicitis; 5. not pregnant; 6. have intact cervix. exclusion criteria: 1. use of any investigational or non-registered product (drug or vaccine)within 30 days preceding the first vaccination, or plan to use during the study period; 2. are using immunosuppressants; 3. administration of immunoglobulin and/or any blood products within the three months preceding the first vaccination or planned administration during the study period; 4. vaccinated of inactivated vaccine 14 days or attenuated vaccine 21 days before the enrollment; 5. fever; 6. concurrently participating another clinical trial; 7. has received vaccines against hpv 16/18 ; 8. immunodeficient; 9. history of allergic disease; 10. serious medical disorders; 11. blood coagulation disorders; 12. epilepsy; 13. unable to comply with protocol due to the mental illness; 14. visible condyloma; 15. pregnant or breast-feeding women; 16. vergins; 17. have more than 4 sexual partners.

Keywords: human papillomavirus 16 human papillomavirus 18 vaccine cervical intraepithelial neoplasia cervical cancer vaginal intraepithelial neoplasia vulvar intraepithelial neoplasia
plaiar-trial: platelets in inflammation and resolution

Conditions: ARDS; Platelet Abnormality

Summary: detection and determination of platelets in bronchoalveolar lavage fluid and blood in ards and non-ards-patients. correlation with phenotype and inflammation parameters in blood and outcome parameters.


Eligibility criteria:
inclusion criteria: * routine bronchoscopy * patient in perioperative setting * age \>=18 years * consent exclusion criteria: * active or recent (in past 7 days) bleeding in upper airways * recent traumatic injury of the lung associated with (micro-)hemorrhage * blood aspiration * pregnancy * age\<18 years * acute kidney injury / chronic kidney failure / dialysis * transplantation * hiv * hematologic diseases * immunosuppression * anti-platelet-therapy
phase 1 trial of cmv towne vaccine in subjects previously received vcl ct02 vaccine id or im

Conditions: Cytomegalovirus Infection

Summary: objectives of this trial are to: 1. evaluate the kinetics and magnitude of the cmv-specific immune response post-towne challenge (3000 pfu) in healthy cmv-seronegative volunteers who received vcl ct02 administered id or im 9 to 15 months previously as measured by: 1) elisa and/or virus-neutralizing antibody titers for gb; 2) t-cell ifn-g elispot; 3) t-cell proliferation assays (cfse) for ie1, pp65, and/or gb; and possibly 4) cytokine and phenotypic flow cytometry responses to pp65, ie1, and/or gb. 2. evaluate the safety safety of towne challenge in healthy cmv-seronegative adult subjects who have previously been immunized with a trivalent pdna cmv vaccine (vcl-ct02) administered intramuscularly (im) or intradermally (id). our hypothesis is that the immune response to towne vaccine 3000 pfu challenge after vlc-ct02 priming will be greater than that after towne vaccination alone (concurrent controls will be administered towne alone in a concurrent, companion trial).

this is a phase 1, single-center, open-label trial of the live, attenuated towne cmv vaccine administered as a "challenge" to healthy, cmv-seronegative, adult subjects who previously received the cmv immunotherapeutic trivalent pdna-based vaccine, vcl-ct02, given by intradermal or intramuscular routes as described in the following table; these subjects have been followed for 32 weeks. table 6.1 subject distribution group formulation dosing regimen (day) dose per injection(administered to the deltoid region) route of administration number of subjects 1. vcl-ct02 0, 28, 56 1.0 mg intramuscular (im) 6 2. vcl-ct02 0, 28, 56 100 μg/injection × 2 injections intradermal (id) 11 total 17 up to 10 subjects from groups 1 and 2 will be approached for enrollment in the current protocol. if a subject consents and meets all eligibility criteria, the subject will receive towne (3000 pfu subcutaneously) between 9 and 15 months after the subject's first dose of vcl-ct02. safety will be monitored and both antibody to cmv gb and t-cell responses to cmv antigens will be measured at specified intervals for 252 days post towne challenge.

Eligibility criteria:
inclusion criteria:18 to 45 years of age at the time of initial enrollment in trial ct02-id; normal lab values at study entry; good general health; cmv igg antibody test \< 4 times last measured value (i.e., at week 32 after vcl-ct02 administration in ct02-id was initiated) - exclusion criteria:cmv seropositive; recent vaccination(s); immunodeficiency; vaccination with investigational cmv vaccine(s) other than vcl-ct02 ; pregnant or breast-feeding -

Keywords: cytomegalovirus vaccine t cell antibodies
depression and anxiety in rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Depression; Anxiety

Summary: the primary endpoint of this study is to evaluate the prevalence of anxiety and depressive disorders, and their relationship with disease activity, in patients with rheumatoid arthritis treated with biological drugs

the prevalence of anxiety and depressive disorders will be assesed with the hads questionnaire at the time of the visit

Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis of rheumatoid arthritis according to 2010 classification american college of rheumatology/ european league against rheumatism (acr/eular) criteria * being able to compile questionnaire * current treatment with biological disease-modifying antirheumatic drug exclusion criteria: * current treatment for anxiety or depressive disorder

Keywords: rheumatoid arthritis depression anxiety das28 hads
effectiveness of primary care physicians in delivering weight control counseling

Conditions: Obesity

Summary: this randomized clinical trial will determine the efficacy of physicians providing weight control advice to their overweight and obese patients in primary care practice.

enrolled physicians are randomly assigned to receive brief training in either: 1) behavioral weight control intervention or 2) obesity education. enrolled patients are asked to see their physician for 2 weight control consultations during the year to discuss their weight and physical activity. regardless of the training the physician receives, the weight control advice is tailored to the individual patient. patients include men and women between the ages of 21 - 70 years, with a body-mass index of 27 or greater, and they have met medical and other study eligibility criteria in order to safely participate. as a participant in the trial, all patients are asked to attend an initial baseline assessment, and two follow-up assessments; 3 and 12 months after their first weight control consultation visit with their physician in order to evaluate any changes in their weight, waist circumference, physical activity, eating patterns, and mood. the findings of this important study will shed light upon the role physician advice may have in helping overweight and obese patients lose weight and become more physically active.

Eligibility criteria:
inclusion criteria: * body-mass index greater than or equal to 27 * able to walk without assistance * no untreated hypothyroidism or cushing disease * no unstable medical or psychiatric condition * no signs or symptoms of cardiovascular disease * no history of gallstones * no terminal illness * no other acute or chronic medical condition in which weight loss is contraindicated * medically cleared for physical activity exclusion criteria: * pregnant, nursing or planning to become pregnant in the next year * had an in-patient hospital stay in the last 3 months * lost more than 10 lbs in the last 4 months * taking an otc or prescribed medication for weight loss * in treatment for an eating disorder * in treatment for depression (if patient is on an anti-depressant and has not had a recent episode of depression in the past 3 months then he/she is eligible)

Keywords: physician education behavioral weight control physician intervention obesity counseling
public health emergency: solidarity trial philippines

Conditions: Covid19

Summary: this study is an adaptive, randomized, open-label, controlled clinical trial utilizing an adaptive design to compare effects of repurposed drugs with local standard of care alone on major inpatient hospital outcomes. this is performed worldwide in collaboration with who.


Eligibility criteria:
inclusion criteria: * consenting adults (age ≥18) hospitalised with the following criteria will be included in the study: 1. probable or confirmed covid-19 regardless of severity, i.e., mild, moderate and severe cases 2. not already receiving any of the study drugs 3. without known allergy or contraindications to any of the study drugs (in the view of the physician responsible for their care), and 4. without anticipated transfer within 72 hours to a non-study hospital. exclusion criteria: * patients with contraindications to any of the study drugs.

Keywords: solidarity hydroxychloroquine lopinavir+ritonavir interferon beta 1a remdesivir
regend001 autologous basal layer stem cell transplantation for interstitial lung disease (ild): a translational application study

Conditions: Interstitial Lung Disease (ILD)

Summary: this clinical trial evaluates the safety and efficacy of regend001, an autologous bronchial basal layer stem cell therapy, in patients with interstitial lung disease (ild). the treatment involves harvesting the patient's own stem cells (expressing krt5/p63 markers), expanding them ex vivo, and administering them via bronchoscopic infusion to regenerate damaged lung tissue.


Eligibility criteria:
inclusion criteria: 1. age 40-75 years. 2. confirmed diagnosis of ild (e.g., ipf, connective tissue disease-associated ild). 3. dlco ≥30% and \<80% predicted. exclusion criteria: 1. pregnancy, lactation, or plans for pregnancy within 1 year. 2. active malignancy or history of malignancy. 3. positive serology for hiv, hbv, hcv, or syphilis.
sust-ains: sustainment of suicide prevention programs in american indian settings

Conditions: Program Sustainability

Summary: the proposed study is part of the research project for a national institute of mental health k01 grant to dr. haroz. the overall research project is focused on understanding how to sustain evidenced-based mental and behavioral health programs in tribal contexts. the aim of this study is to pilot test sustainment strategy interventions across tribal settings using mixed-methods.

among the most pressing issues in mental health dissemination and implementation research (d\&i) is the lack of knowledge about how to sustain mental health prevention and treatment services for which there is substantial evidence of impact. most d\&i studies focus on adoption and initial implementation, with few studies (\<20) rigorously exploring sustainment. the sustainment of services has been described as "one of the greatest, yet least understood, challenges in the field of implementation science." the gap in knowledge is even greater for low-resource contexts, as few studies have focused on these settings. this project aims to address this gap by developing and testing sustainment strategies for an evidenced-based youth suicide prevention program in a low-resource, american indian (ai) contexts.

Eligibility criteria:
inclusion criteria: * knowledgeable about the implementation of the suicide prevention program * over the age of 18 * available to participate in required study meetings and assessments * fluent in english exclusion criteria: * factors identified at baseline that preclude full participation including: being under the influence of a substance; active psychosis or mania; any other condition that makes an individual lack capacity to give consent.